Ultrasound-assisted Versus Conventional Landmark-guided Spinal Anesthesia in Patients With Abnormal Spinal Anatomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- the number of needle passes
研究概览
简要总结
Spinal anesthesia can be challenging in patients with lumbar scoliosis or previous lumbar spine surgery. This study aims to evaluate whether the use of the ultrasound-assisted spinal anesthesia reduces the number of passes required to successful dural puncture compared with the conventional surface landmark-guided technique in patients with abnormal spinal anatomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients scheduled to undergoing elective orthopedic surgery under spinal anesthesia,
- •with ASA physical status classification I, II, III,
- •and with (1) or (2)
- •documented scoliosis in preoperative L-S-Spine X-ray (Cobb abgle > 10 degree)
- •previous history of lumbar spinal surgery
排除标准
- •Patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic)
- •Patients with morbid cardiac diseases
- •Pregnancy
研究组 & 干预措施
Ultrasound-assisted
Preprocedural ultrasound-assisted paramedian spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.
干预措施: Ultrasound-assisted paramedian spinal anesthesia (Procedure)
Ultrasound-assisted
Preprocedural ultrasound-assisted paramedian spinal anesthesia will be performed. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.
干预措施: 0.5% heavy bupivacaine (Drug)
Landmark-guided
Landmark-guided spinal anesthesia will be performed, via either midline or paramedian approach. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.
干预措施: Landmark-guided spinal anesthesia (Procedure)
Landmark-guided
Landmark-guided spinal anesthesia will be performed, via either midline or paramedian approach. 0.5% heavy bupivacaine will be injected to intrathecal space for spinal anesthesia.
干预措施: 0.5% heavy bupivacaine (Drug)
结局指标
主要结局
the number of needle passes
时间窗: Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection)
the number of forward advancements of the spinal needle in a given interspinous space, i.e., withdrawal and redirection of spinal needle without exiting the skin
次要结局
- Periprocedural pain(Patients will be asked immediately after the completion of spinal anesthesia)
- Time taken for performing spinal anesthetic(Intraoperative (from insertion of the needle to the completion of injection))
- dermatome level of sensory block(5, 10, 15 minutes after the completion of spinal anesthetic injection)
- Periprocedural discomfort score(Patients will be asked immediately after the completion of spinal anesthesia)
- Number of spinal needle insertion attempts(Intraoperative (from the first insertion of needle to patient's skin, until the completion of spinal anesthetic injection))
- Time for identifying landmarks(1 day (time taken for establish the landmark, from start of palpation/US scanning to completion of palpation/scanning))
- Incidence of radicular pain, paraesthesia, and blood tapping in the spinal needle(Intraoperative (from the first insertion of needle, until the completion of spinal anesthetic injection))
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital